Events

Alerta De Seguridad para ViewPoint 6

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por GE Healthcare.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2013-08-05
  • Fecha de publicación del evento
    2013-08-05
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130805a.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: ge healthcare viewpoint 6 the australia therapeutic goods administration (tga) has posted a medical device safety alert concerning viewpoint 6 versions 6.2, 6.2.1, 6.3 and 6.31 including ob pro-expert reporting (ultrasound image management software) manufactured by ge healthcare. ge healthcare has become aware of a potential safety issue due to the incorrect calculation of the pulsatility index value (piv) for venous flow measurements. the ductus venous piv measurement can be incorporated into the first trimester risk assessment for chromosomal abnormalities. in case of negative flow patterns, the viewpoint calculated doppler piv for veins could be incorrect, leading to a false high risk for trisomy 13, 18, and 21. ge healthcare is advising users to discontinue use of venous piv for making any clinical decisions, in particular, discontinue use of the ductus venous piv for first trimester risk assessment. in addition, ge healthcare will be providing a software upgrade as a permanent fix. for details, please visit the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-00812-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 5 august 2013.

Device

ViewPoint 6
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: GE Healthcare ViewPoint 6
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare